Methods for Counteracting Rebounding Effects During Solid State Resistance Welding of Dissimilar Materials

ABSTRACT

The present disclosure is directed to a multi-segment device, such as an intravascular guide wire. The multi-segment device includes an elongate first portion comprising a first metallic material, an elongate second portion comprising a different metallic material, the first and second elongate portions being directly joined together end to end by a solid-state weld, and a heat affected zone surrounding an interface of the weld where the first and second portions are joined together, wherein the heat affected zone has an average thickness of less than about 0.20 mm.

CROSS-REFERNCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/494,970, filed 24 Apr. 2017, which is a divisional of U.S. patentapplication Ser. No. 13/744,276, filed 17 Jan. 2013, now U.S. Pat. No.9,636,485, the disclosures of which are incorporated herein by referencein their entireties.

BACKGROUND

The human body includes various lumens, such as blood vessels or otherpassageways. A lumen may sometimes become at least partially blocked orweakened. For example, a lumen may be at least partially blocked by atumor, by plaque, or both. An at least partially blocked lumen may bereopened or reinforced with an implantable stent.

A stent is typically a tubular body that is placed in a lumen of thebody. A stent may be delivered inside the body by a catheter thatsupports the stent in a reduced-size configuration as the stent isdelivered to a desired deployment site within the body. At thedeployment site, the stent may be expanded so that, for example, thestent contacts the walls of the lumen to expand the lumen.

A guide wire may be employed when delivering a delivery catheter andstent to a desired location. For example, a guide wire may be advancedthrough a guiding catheter until the distal tip of the guide wireextends just beyond the location where the stent is to be implanted. Acatheter and a stent to be positioned may be mounted onto the proximalportion of the guide wire, and the catheter and stent may be advancedover the guide wire until the catheter and stent are disposed within theblood vessel or other passageway where the stent is to be implanted.Once the stent is implanted, the catheter may be withdrawn over theguide wire. The guide wire may also be withdrawn.

Guide wires may often include an elongate core member with one or moresegments near the distal end which taper distally to smallercross-sections. A helical coil or other flexible body member may bedisposed about the distal end of the guide wire. A shaping member, whichmay be at the distal extremity of the core member, may extend throughthe flexible body and be secured to the distal end of the flexible bodyby soldering, brazing, welding, an adhesive, etc. The leading tip of thestructure may be highly flexible in order not to damage or perforate theblood vessel or other passageway. The portion proximal to the distal tipmay be increasingly stiff, to provide the ability to support a ballooncatheter or similar device.

One major requirement for guide wires is that they provide sufficientcolumn strength to be pushed through the patient's vasculature or otherbody lumen without buckling. On the other hand, they must besufficiently flexible to avoid damaging the body lumen as they areadvanced. Efforts have been made to improve both strength andflexibility of guide wires to make them more suitable for thesepurposes, although these two desired characteristics are generallydiametrically opposed to one another, such that an improvement in onetypically results in less satisfactory performance relative to theother.

Despite a number of different approaches for addressing these issues,there still remains a need for improved guide wires and associatedmethods of manufacture.

SUMMARY

For instance, in one configuration, the present disclosure is directedto methods for joining members of different metallic materials that areincompatible with one another. In one embodiment, multiple initiallyseparate members are provided, which members comprise differentmaterials (e.g., one member may comprise a nickel-titanium alloy such asnitinol, while another member may comprise stainless steel). Theseparate members are aligned with one another, and a first force isapplied while delivering electrical (e.g., DC, AC, or both) currentthrough the separate members so as to weld the separate portions to oneanother. During welding, the applied electrical (e.g., DC, AC, or both)current serves to heat the portions of the members to be joined so thatthey undergo solid state deformation, such that the materials are notmelted, but deform and form a weld joint while in a solid state. Afollow up force that is greater than the first force is applied to themembers as deformation of the members occurs. The deformation results information of a weld nugget between the members. Because of applicationof the follow up force, the nugget is thinner and of a larger transversecross-sectional area than would be produced without application of thefollow up force. In an embodiment, the follow up force may be appliedafter some (e.g., most or all) electrical weld energy has been delivered(e.g., after current delivery stops), but before deformation (i.e.,setdown) has been completed. In an embodiment, the method may beemployed to join separate elongate segments or portions of anintravascular guide wire to one another, end-to-end.

Application of a follow up force, rather than increasing the amount ofweld energy applied (e.g., in the form of DC or AC current) acts toincrease solid state deformation (i.e., forging) without having to raisethe temperature of the weld material via input of additional weldenergy. This in effect avoids an undesirable tradeoff associated withincreasing solid state deformation to enlarge and flatten the weldnugget by increasing electrical weld energy input. While an increase inelectrical weld energy input may act to increase solid statedeformation, it undesirably increases risk of melting, which adverselyimpacts weld integrity due to metallurgical incompatibility betweendissimilar materials such as nitinol and stainless steel. Application ofa follow up force that is greater than the baseline force applied duringdelivery of the electrical weld energy enables weld nugget deformationto be substantially increased while maintaining appropriate temperaturesto avoid melting.

One embodiment is directed to a method for joining a multi-segmentintravascular guide wire in which multiple initially separate portionsof the guide wire are provided, the portions comprising differentmetallic materials. Each portion includes an end to be joined to acorresponding end of another portion (e.g., the portions may be joinedend to end). Corresponding ends of the guide wire portions may beprepared to flatten and smooth the corresponding ends (and to remove anyoxide layer) prior to axial alignment and welding. The correspondingends may be axially aligned with one another, and a first axial force isapplied while delivering electrical (e.g., DC, AC, or both) currentthrough the separate guide wire portions to weld the separate guide wireportions to one another. A follow up axial force that is greater thanthe first axial force is applied after electrical (e.g., DC, AC, orboth) current delivery has stopped and before rebounding occurs, asaxial deformation of the guide wire portions forms a weld nugget betweenthe guide wire portions. The thus formed weld nugget is thinner and of alarger transverse cross-sectional area than would be produced withoutapplication of the follow up axial force.

The methods of manufacture herein described can be used to producemulti-segment intravascular guide wires with distinguishingcharacteristics as compared to those produced without application of thefollow up force. For example, a multi-segment intravascular guide wiremay include a first portion comprising a first metallic material, asecond portion comprising a second metallic material different from thefirst material, in which the first and second portions are directlyjoined together end to end by a weld. A heat affected zone is disposedat the location of the weld where the first and second portions arejoined together. The heat affected zone corresponds to the weld nugget,and may typically exhibit hardness characteristics different fromadjacent portions of the first and second portions that were notaffected by the heat associated with solid state deformation andformation of the weld nugget. The heat affected zone may have a length(e.g., less than 0.20 mm) that is less than a heat affected zone of anotherwise similarly formed multi-segment intravascular guide wire, butformed without application of the follow up force. The shorter heataffected zone may provide increased kink resistance. In addition to theshorter heat affected zone the weld exhibits strength characteristicsthat are more consistent from one manufactured guide wire to another.

Features from any of the disclosed embodiments may be used incombination with one another, without limitation. In addition, otherfeatures and advantages of the present disclosure will become apparentto those of ordinary skill in the art through consideration of thefollowing detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify at least some of the advantages and features of thepresent disclosure, a more particular description of the disclosure willbe rendered by reference to various embodiments thereof that areillustrated in the appended drawings. It is appreciated that thesedrawings depict only various embodiments of the disclosure and aretherefore not to be considered limiting of its scope. The variousembodiments will be described and explained with additional specificityand detail through the use of the accompanying drawings in which:

FIG. 1 is a side elevation and partial cross-sectional view of amulti-segment intraluminal guide wire according to an embodiment of thepresent disclosure;

FIG. 2 is a simplified side elevation view of a multi-segmentcore-to-tip intraluminal guide wire according to an embodiment of thepresent disclosure;

FIG. 3 is a flow chart illustrating a method for joining a multi-segmentintravascular guide wire according to an embodiment of the presentdisclosure;

FIG. 4 is a plot showing an electrical weld energy input profile and anaxial displacement profile for butt welding dissimilar guide wiresegments without application of any follow up axial force;

FIG. 5 is a plot showing an electrical weld energy input profile and anaxial displacement profile for butt welding dissimilar guide wiresegments with application of follow up axial force;

FIG. 6 is a plot showing the axial displacement profiles of FIGS. 4 and5 on a single plot, illustrating the change in slope of the axialdisplacement profile where follow up force is applied;

FIG. 7A is a close up side elevation view showing the heat affected zoneand weld nugget formed under the conditions associated with FIG. 4,without application of follow up force;

FIG. 7B is a side elevation view showing the heat affected zone and weldnugget formed under the conditions associated with FIG. 5, includingapplication of follow up force;

FIG. 8A is a photograph of a weld nugget formed under the conditionsassociated with FIG. 4; and

FIG. 8B is a photograph of a weld nugget formed under the conditionsassociated with FIG. 5.

FIGS. 9A-9E show images of multi-segment guide wires according to thepresent disclosure.

FIGS. 10A-10F show images of Terumo guide wires.

DETAILED DESCRIPTION I. Introduction

For instance, in one configuration, the present disclosure is directedto methods for joining members of different metallic materials. Themethod includes providing multiple initially separate members, whichmembers comprise different metallic materials (e.g., nitinol andstainless steel). The separate members are aligned with one another, anda first force is applied while delivering electrical (e.g., DC, AC, orboth) current through the separate members to weld the separate membersto one another. A follow up force that is greater than the first forceis applied as solid-state deformation occurs and a weld nugget formsbetween the members. The resulting weld nugget is thinner and of alarger transverse cross-sectional area than would be produced withoutapplication of the follow up force. The method may be employed to joinseparate elongate segments or portions of an intravascular guide wire toone another, end-to-end.

The present manufacturing methods may be employed with respect to anydesired medical or other devices where it is desired to join twodissimilar metals together with a weld formed under solid statedeformation conditions, without melting the materials. For example, whenjoining members comprising dissimilar, and possibly incompatible metals(e.g., titanium in one segment and iron in another member), melting ofthe metal members during a welding procedure can result in formation ofbrittle, undesirable intermetallic compounds. Other incompatibilitiesmay similarly present a situation in which it is desired to join twodissimilar metallic members together, while minimizing risk of melting,which for one reason or another may complicate or exacerbate anyincompatibilities of the two materials.

While melting is unacceptable, it has also been recognized that directwelding of dissimilar, incompatible materials to one another, such asstainless steel and nitinol has been a practical impossibility. While intheory one might hope to be able to directly join such dissimilar metalstogether through a welded joint formed under solid state deformation,rather than melting, up to now, this has proven to be a practicalimpossibility, at least on a commercial scale, while meeting applicablequality control standards. Given these practical difficulties, varioustechniques have been employed to directly join two such dissimilarmaterials together. For example, U.S. Pat. No. 7,998,090 describes useof a transition piece (e.g., formed of nickel) employed between theotherwise incompatible segments to indirectly join the two segmentstogether. Another technique may employ an adhesive, rather than a weldedjoint to connect the dissimilar segments comprising incompatible metals.Such an adhesive joint may include a coupling, which component isrelatively costly.

The methods of the present disclosure advantageously provide the abilityto directly join two dissimilar metal members (e.g., nitinol andstainless steel) with a weld formed under solid state deformationconditions, while providing a high level of consistency (i.e., reducedor low variability) to the strength of the weld. As such, the method issuitable for commercial use so as to produce a high volume ofmulti-member components comprising dissimilar metals exhibitingconsistent strength characteristics so as to consistently meet desiredquality control standards.

II. Example Intravascular Multi-Segment Guide Wires

In an embodiment, the methods are employed to join two segments orportions of a multi-segment guide wire where the segments or portionscomprise different metallic materials. The terms segment and portion maybe used interchangeably herein to refer to segments or portions of themulti-segment guide wire. FIG. 1 is an elevation side view and partialcross-section view of a guide wire 100 including features according tothe present disclosure. Guide wire 100 may be adapted for insertion intoa body lumen of a patient, for example a vein or artery. Guide wire 100may include an elongate, relatively high strength proximal core portion102 directly welded to a relatively flexible distal core portion 104 atweld joint 103. Weld joint 103 may be surrounded by a heat affected zone105 as will be described below. Distal core portion 104 may include atapered section 106, tapering to a smaller thickness in the distaldirection. A helical coil 108 may be disposed about distal core section104, which may be secured by its distal end to a distal end of shapingribbon 110 (e.g., by solder) near rounded plug 112.

A proximal end of shaping ribbon 110 may be secured (e.g., by solder) todistal core portion 104 at the same or a nearby location 114. A distalsection 116 of coil 108 may be stretched in length to provide additionalflexibility. Distal tip 118 of distal core portion 104 may be flattenedinto a rectangular cross-section, and may include a rounded tip 120(e.g., solder) to prevent passage of distal tip 118 through any spacesbetween the coils of helical coil 108.

FIG. 2 shows a simplified embodiment of another intravascular guide wire200 including features of the present disclosure. Core portions 202 and204 may be directly welded together at weld joint 203 duringfabrication. Similar to guide wire 100, weld joint 203 includes a heataffected zone surrounding joint 203 as a result of the solid statedeformation of the materials within this region. Portion 202 maycomprise a material (e.g., stainless steel) having a relatively highermodulus of elasticity. A distal end of portion 202 may be directlyjoined through a weld (e.g., a butt weld) formed through solid statedeformation to distal portion 204, which comprises a different material(e.g., nitinol), having a relatively lower modulus of elasticity. Distalportion 204 may include a flattened, shapeable distal tip 218 which canbe permanently deformed (e.g., by finger pressure) to create a tip thatcan be steered through a patient's vasculature. As shown, distal tip 218may be bent or deformed into a J, L or similar bend 219. A tip coil 208may be disposed over distal core portion 204.

The illustrated configurations for guide wires 100, 200 are merely twoof many possible configurations, and other guide wire configurationsincluding multiple segments that may be directly joined together by aweld formed under solid state deformation conditions are encompassed bythe present disclosure.

Distal core section 104, 204 may be made of a nickel-titanium alloy suchas nitinol, a pseudoelastic alloy including about 30 atomic percent toabout 52 atomic percent titanium, with the balance typically beingnickel. Optionally, up to about 10 atomic percent or up to about 3atomic percent of one or more other alloying elements may be included.Other alloying elements include, but are not limited to iron, cobalt,vanadium, platinum, palladium, copper, and combinations thereof. Wherecopper, vanadium, or combinations thereof are included, each may beincluded in amounts of up to about 10 atomic percent in one embodiment.In one embodiment, where iron, cobalt, platinum, palladium, orcombinations thereof are included, each may be included in amounts of upto about 3 atomic percent.

Addition of nickel above equiatomic amounts relative to titaniumincreases stress levels at which the stress induced austenite tomartensite transition occurs. This characteristic can be used to ensurethat the temperature at which the martensitic phase thermally transformsto the austenitic phase is well below human body temperature (37° C.) sothat the austenite is the only temperature stable phase at bodytemperature. Excess nickel may also provide an expanded strain range atvery high stresses when the stress induced transition occurs during use.

Because of the extended strain range characteristic of nitinol, a guidewire having a distal portion made at least in substantial part of suchmaterial can be readily advanced through tortuous arterial passagewayswith minimal risk of kinking. Such characteristics are similarlybeneficial where the distal nitinol portion of the guide wire may beprolapsed, either deliberately or inadvertently.

The proximal portion 102, 202 of guide wire 100, 200 may typically besignificantly stronger (i.e., having higher tensile strength) thanpseudoelastic distal portion 104, 204. For example, proximal portion102, 202 may be formed of stainless steel (e.g., SAE 304 stainlesssteel). Other high strength materials, including, but not limited tocobalt-chromium alloys such as MP35N may also be employed.

As described above, prior attempts to directly weld such incompatible,dissimilar materials to one another have been very challenging, and as apractical matter impossible. For example, even if a weld connection canbe made, localized damage within the heat affected zone associated withthe weld often results in weld integrity that may be diminishedseemingly at random, with no known nondestructive method of detection.Thus, such welded components, even if successfully joined together bywelding, have been found to exhibit undesirably high variations in weldstrength, which can lead to unpredictable failure of the weld prior to,or worse yet, during use.

Because of these difficulties in directly welding such dissimilar andincompatible materials together, such direct weld connections have beenavoided. Rather, the dissimilar, incompatible segments have beenindirectly joined to one another by employing a transition piecepositioned between the incompatible materials, or by joining themwithout resorting to a weld (e.g., use of an adhesive and/or acoupling). Such solutions result in increased complexity and cost.Methods that would provide the ability to directly join dissimilar,incompatible metal materials together through a welded joint, whileproviding low levels of variability (i.e., high levels of consistency)of weld strength would be a marked advance in the art. The presentdisclosure describes such methods of manufacture and correspondingmulti-segment intravascular guide wires so formed.

III. Embodiments of Methods for Joining Segments of Multi-SegmentIntravascular Guide Wires

In an embodiment, the present methods may achieve direct joining ofdissimilar metal materials to one another through a resistance,solid-state welding process in which the segments may be welded to oneanother. The welding process achieves the desired direct joint throughsolid state deformation of the ends of the two segments, without meltingof either material. Such a method is particularly advantageous in thefield of intravascular guide wires where the wire segments to be weldedto one another are relatively small, such that known methods of solidstate deformation weld bonding are unsuitable. For example, weldingprocesses capable of reliably joining dissimilar metals together withoutmelting of either work piece are known. Such methods involve solid statebonding, rather than melting and fusion. A metallurgical bond is createdwhile both materials remain in the solid state, typically throughapplication of heat and pressure at the interface of the dissimilarmetals.

The earliest developed method, known as forge welding, employs theblacksmith's technique of heating both work pieces near but below theirrespective melting points and forcing them together via successivehammer blows. Such a method is of course not suitable for welding finewires together end-to-end, as may be required when joining multiplesegments of a multi-segment intravascular guide wire. Another solidstate joining method, explosion welding, uses an engineered explosivecharge to generate extremely high velocity and resulting highinterfacial pressure between the pieces to be joined together. Such amethod is employed in laminating sheet and plate materials, although itis not suitable for joining together fine wires.

U.S. Pat. No. 7,998,090 suggests another solid-state bonding techniquewhich the reference describes as a hybrid of resistance welding andfriction welding. Even so, this reference concludes that directconnection of dissimilar, incompatible materials such as nitinol andstainless steel is a practical impossibility, relying instead on theplacement of a transition piece comprising a third material (e.g.,nickel) that exhibits compatibility to both of the dissimilar,incompatible pieces therebetween. As described above, such methods areoverly complicated and costly.

The present methods overcome the difficulties previously encounteredwhen attempting to directly weld two dissimilar wire segments, forexample end-to-end as in a multi-segment guide wire. As shown in FIG. 3,according to method S10, multiple, initially separate portions of theguide wire, each comprising a different material, are provided at S12.Although FIGS. 1 and 2 show embodiments including two segments, it willbe understood that the methods herein described may similarly beemployed to join more than two segments together, without the need toposition any transition piece between the incompatible, dissimilar metalsegments for compatibility purposes. For example, were three segmentsdesired, two segments may be joined, followed by joining the resultingstructure with a third segment. At S14, the separate portions orsegments are aligned (e.g., axially, end-to-end) with one another. Asindicated at S16, a first force (e.g., axial) is applied whiledelivering electrical (e.g., DC, AC, or both) current through theseparate guide wire portions to begin directly welding the separateportions or segments to one another. At S18, a follow up force (e.g.,axial) that is greater than the first force is applied as solid statedeformation occurs, and as the weld nugget forms between the guide wireportions or segments. As indicated at S20, the resulting weld nugget isthinner and of a larger transverse cross-sectional area than would beproduced without application of the follow up force. The method has beenfound to effectively and reliably directly join two dissimilar,incompatible elongate wire segments or portions to one another, whileconsistently achieving desired strength characteristics.

Prior to aligning the corresponding ends of the separate guide wireportions, the ends to be joined together may be prepared by flatteningand smoothing the ends. Such end preparation may be achieved by grindingthe mating ends just prior to alignment and the beginning of the weldingprocess (i.e., when the first force is applied and electrical current isdelivered through the segments). This may be so, even where the ends mayhave been smoothed and flattened previously, as removal of any oxidelayers at this stage is desirable. According to one such method, theends may be ground with a rotating disc covered with wet or drysandpaper. An aqueous grinder coolant may serve to remove debris duringthe grinding step. Such a flattening and smoothing procedure acts toremove oxide from the wire ends, which oxide may otherwise interferewith the ability to achieve sufficient and consistent weld strength. Forexample, in the case of nitinol and stainless steel wire segments thenitinol forms a titanium oxide layer, while the stainless steel includesa chromium oxide layer. It is beneficial to remove these oxide layersfrom the corresponding ends that are to be welded together. Removal ofany oxide layers (e.g., preferably performed immediately prior to axialalignment and welding) minimizes contact resistance and reducesvariability in contact resistance due to the presence of the oxidelayers. This helps reduce variability in weld temperature from one weldto another, which helps in ensuring that no melting of either metal ofthe dissimilar wire segments occurs.

As used herein, when referring to preparation of the corresponding endsbeing performed “immediately prior to” or “just prior to” axialalignment and welding, it will be understood that some passage of timebetween preparation of the corresponding ends of the segments orportions to be joined together and axial alignment and butt welding ofthe segments or portions is acceptable so long as such time period issufficiently short so as to prevent reformation of an oxide film overthe prepared ends which could affect the contact resistance between saidends. For example, in one embodiment, preparation of the ends isperformed within about 1 day of welding, within about 10 hours ofwelding, within about 1 hour of welding, within about 30 minutes ofwelding, within about 15 minutes of welding, within about 5 minutes ofwelding, within about 2 minutes of welding, or within about 1 minute ofwelding.

In addition, to prevent formation of an oxide layer over the preparedends during resistance heating, the ends may be tightly pressed together(e.g., about 100,000 psi to about 200,000 psi) through application ofthe first force prior to application of any electrical (e.g., DC, AC, orboth) current so as to prevent any air from being present therebetweenthat might result in reformation of the oxide layers. If desired,resistance heating and the application of the forces associated with thewelding process may be undertaken in an inert environment, which mayfurther aid in preventing formation of any undesirable oxide layers thatwould interfere with contact resistance and maintaining weld temperaturewithin the desired window.

The baseline first force may be applied axially, and applied at anydesired level, which may depend at least in part on the dimensions andmaterial characteristics of the wire segments to be joined together. Inone example, the force applied may be from about 1 lb to about 100 lbs,from 5 lbs to 50 lbs, from about 10 lbs to about 30 lbs, or from about15 lbs to about 25 lbs. Where the process is employed to join relativelythin, elongate wire segments, such levels of force may result inpressures from about 100,000 psi to about 200,000 psi. For example, whenjoining wire segments each having a diameter of about 0.013 inch andapplying a baseline force of 20 lbs, the resulting pressure at theinterface is about 150,000 psi.

The baseline force and the cross-sectional thickness of the wiresegments may result in a pressure at the interface of the segments fromabout 35,000 psi to about 400,000 psi, from about 75,000 psi to about250,000 psi, or from about 100,000 to about 200,000 psi. Wire segmentshaving relatively larger cross-sectional area may be processed atrelatively higher force levels to provide similar pressures. Forexample, a force of 20 lbs and a wire diameter of 0.013 inch results ina pressure of about 150,000 psi, while a force of 47 lbs and a wirediameter of 0.020 inch also results in a pressure of about 150,000 psi.In an embodiment, the wire segments so joined may have about the samediameter (e.g., within about 25%, within about 10%, within about 5%, orwithin about 1% of one another). In one embodiment, the wire segmentdiameters may be approximately equal (e.g., both about 0.013 inch).

The baseline force may be applied while electrical (e.g., DC, AC, orboth) current is applied to the segments. The value of the baselineforce may be substantially constant over the period over which it isapplied. As weld energy is input in the form of applied electrical(e.g., DC, AC, or both) current, the regions adjacent the correspondingends which are pressed together will begin to soften as the temperatureincreases. At some point, these regions will begin to collapse towardsone another (i.e., solid state deformation) as setdown or axialdisplacement occurs, as a result of solid-state deformation.

Electrical weld energy input (i.e., application of electrical (e.g., DC,AC, or both) current) may last from about 1 ms to about 100 ms, fromabout 5 ms to about 50 ms, or from about 10 ms to about 30 ms. The valueof the applied current may depend on duration of the input, as well asthe dimensions and material characteristics of the segments being joinedtogether. In one embodiment, the applied current may be from about 0.01kA to about 0.1 kA, from about 0.05 kA to about 0.08 kA, or from about0.06 kA to about 0.07 kA. Of course, larger or smaller values than theseranges may be appropriate where the dimensions and/or materialcharacteristics of the segments so dictate. Applied current may be DCcurrent, AC current, or both. For example, an embodiment may employ ahigh frequency inverter power source which may provide a DC pulse thatmay include high frequency AC overlaid on it. Such a power source maydiffer from standard AC in that the high frequency potential may notcompletely reverse polarity.

The follow up force (e.g., axial) is applied after solid-statedeformation (setdown) begins, but before such deformation has completed.The follow up force may be applied after some (e.g., most or all) of theelectrical weld energy has been delivered (e.g., the electrical (e.g.,DC, AC, or both) current delivery may have stopped). In one embodiment,there is a gap between when electrical weld energy input stops and thestart of application of the follow up force. For example, application ofthe follow up force may begin from about 0.5 ms to about 10 ms after theend of electrical (e.g., DC, AC, or both) current delivery, from about 2ms to about 8 ms after the end of electrical (e.g., DC, AC, or both)current delivery, or from about 3 ms to about 5 ms after the end ofelectrical (e.g., DC, AC, or both) current delivery.

As with the baseline force, the value of the applied follow up force maydepend on the material characteristics and dimensions (e.g., diameter)of the segments being directly joined together. In one embodiment, thefollow up force may be from about 2 lbs to about 200 lbs, from about 10lbs to about 100 lbs, from about 20 lbs to about 60 lbs, or from about30 lbs to about 40 lbs. The follow up force and the cross-sectionalthickness of the wire segments may result in a pressure at the interfaceof the segments from about 50,000 psi to about 750,000 psi, from about125,000 psi to about 450,000 psi, or from about 175,000 to about 350,000psi. For example, a follow up force of 35 lbs and a wire diameter of0.013 inch results in a pressure of about 265,000 psi. In oneembodiment, the follow up force and/or the pressure provided by thefollow up force is from about 10% greater to about 200% greater than thebaseline force (or baseline pressure), from about 25% greater to about150% greater than the baseline force (or baseline pressure), or fromabout 50% greater to about 100% greater than the baseline force (orbaseline pressure).

FIGS. 4 and 5 plot electrical weld energy input and axial deformationprofiles for directly butt welding a stainless steel proximal guide wireportion to a nitinol distal guide wire portion. Each portion had adiameter of about 0.013 inch. The profiles shown in FIG. 4 are withoutapplication of a follow up axial force, while the profiles shown in FIG.5 are with application of a follow up axial force.

As seen in FIG. 4, electrical weld energy input was ramped over a periodof 20 ms to a value of about 0.061 kA. The baseline axial force appliedwas at a value of 20 lbs. In FIG. 5, current application was similarlyramped over a period of 20 ms to a value of about 0.061 kA. The baselineaxial force applied was also at a value of 20 lbs. About 4 ms aftercurrent delivery stopped, once axial displacement (setdown) had begun,the force was increased to 35 lbs. In FIG. 4, the total axialdisplacement or setdown was 0.0381 inch. In FIG. 5, the total axialdisplacement or setdown was 0.0402 inch. The greater axial displacementvalue of FIG. 5 corresponds to a weld nugget of thinner cross-sectionalthickness and greater transverse cross-sectional diameter than that ofFIG. 4. Photographs of the two weld nuggets so formed are shown in FIGS.8A and 83B.

FIG. 6 shows the axial displacement profiles of FIGS. 4 and 5 on thesame plot. The plotted profiles A and B begin substantially parallel toone another, with the divergence beginning at the point where the followup axial force is applied in example B and not example A.

Application of a follow up axial force of greater value than thebaseline axial force has been found to eliminate unacceptablevariability in weld strength that is due to mechanical rebounding.Rebounding is believed to be a natural consequence of the suddencollapse of weld material when heated abruptly under an axial load. Forexample, rebounding may occur with the abrupt halt of axial deformationduring formation of the weld nugget as a sliding wire grip that gripsthe respective wire segments reverses direction and thereby applies avarying load to the newly formed weld. This may result in brief tensileloading on the weld, even though only compressive loading is intended.While such mechanical rebounding is present in both of theconfigurations described in conjunction with FIGS. 4 and 5, a largerdiameter weld nugget (associated with FIG. 5), including increasedcross-sectional area at the interface between the dissimilar,incompatible materials serves to better accept such a transitory tensileload without pulling the weld apart or resulting in hidden damage withinthe weld nugget that might later lead to failure of the guide wire atthe weld. In addition, application of the follow up force serves tosqueeze and thereby extract heat from the weld nugget whilesubstantially enlarging its cross-sectional area. Extraction of heatserves to decrease the temperature of the weld nugget, particularly itsinterface, thereby raising its strength and further improving itsresistance to rebounding forces.

FIG. 7A depicts an exemplary proximal and distal portion 302 and 304,respectively of a multi-segment guide wire 300 in the vicinity of theformed weld nugget. FIG. 7A corresponds to FIG. 4, which does notinclude application of any follow up force. FIG. 7B depicts proximal anddistal portions 302′ and 304′, respectively of a multi-segment guidewire 300′ formed with application of a follow up axial force(corresponding to FIG. 5). These depictions correspond to the actualphotographs shown in FIGS. 8A and 8B. In each, the weld nugget 322 and322′ is seen disposed surrounding the interface where the respectiveproximal and distal portions are joined together. In one embodiment,weld nugget 322′, formed under conditions in which a larger follow upaxial force is applied, exhibits a diameter D′ that is at least about 5%greater, at least about 10% greater, or about 15% greater to about 25%greater than diameter D that would be produced without application ofthe follow up axial force. Stated another way, where the diameter D′ isabout 20% larger in weld nugget 322′ than diameter D of weld nugget 322,the cross-sectional area of weld nugget 322′ will be about 45% greaterthan the cross-sectional area of weld nugget 322. This significantlyincreased cross-sectional area (i.e., increased bonding area) betterresists undesirable tensile loading due to mechanical rebounding.

Related to this characteristic of increased diameter and cross-sectionalarea, weld nugget 322′ may have an average thickness T′ that is fromabout 10% smaller to about 50% smaller, about 15% smaller to about 35%smaller, or about 20% smaller to about 30% smaller than thickness T thatwould be produced without application of the follow up axial force.

The actual weld nuggets shown in FIGS. 8A and 8B exhibited an averagethickness of 0.22 mm without application of a follow up force, and anaverage thickness of 0.15 mm with application of a follow up force. Theresulting diameter shown in FIG. 8B was 20% larger than that shown inFIG. 8A, providing an increase in cross-sectional bonded surface area of45%.

While the embodiments described in FIGS. 4-8B are shown as being carriedout under conditions in which the corresponding ends of the segments orportions are shaped and oriented to provide a butt joint as a result ofthe weld, it will be understood that other welded joint configurations,including but not limited to butt joints, overlap joints, jointsincluding corresponding oblique angled ends, and combinations thereofmay also be employed. Various alternative joint configurations that maybe employed are shown in U.S. Pat. No. 7,998,090, herein incorporated byreference in its entirety.

Once the two segments have been joined together, the weld nuggetdisposed therebetween can be removed by grinding. For example, themajority of the excess weld nugget material extending laterally beyondthe diameter of the adjacent proximal and distal segments may be groundaway in a centerless grinding operation. Any remaining excess metal maybe removed while grinding the entire distal core wire profile. Inaddition to simply allowing direct joining of dissimilar metallicmaterials to one another with a solid-state weld joint, multi-segmentguide wires formed as described herein with application of an increasedfollow up force exhibit characteristics allowing them to be identifiedas having been produced according to such methods herein described. Forexample, in one embodiment, the resulting multi-segment guide wireincludes a heat affected zone corresponding to the location of the weldnugget. In one embodiment, such a multi-segment guide wire may have aheat affected zone that has a thickness of less than about 0.20 mm, lessthan about 0.18 mm, or from about 0.15 mm to about 0.18 mm in thickness.Such reduced thickness heat affected zones provide improved kinkresistance. The heat affected zone may also exhibit unique hardnesscharacteristics as a result of the heat affected zone having undergonegreater levels of solid state deformation arising from the follow upforce. Specifically, the heat affected zone is expected to be narrowerand exhibit a lesser degree of softening as compared with welds createdwithout a follow up force.

Comparative measurements of the heat affected zone (e.g., the weldwidth) were carried out on multi-segment guide wires according to thepresent disclosure as compared to Terumo guide wires. Measurement ofmicrohardness impressions within the stainless steel portion, thenickel-titanium portion, and the heat affected weld zone therebetweenwere taken using Vickers hardness testing. Each Vickers hardnessmeasurement was made using 100 grams of force (HV100). Threemeasurements within each region were obtained. The results are shown inTables 1A and 1B. AV1, AV2, and AV3 refer to multi-segment guide wiresaccording to the present disclosure. T1, T2, and T3 refer to hardnesstested Terumo guide wires.

TABLE 1A AV1 AV2 AV3 T1 T2 T3 Region (HV) (HV) (HV) (HV) (HV) (HV) NiTi₁393 389 376 — 315 334 NiTi₂ 385 371 381 279 292 329 NiTi₃ 379 381 352290 274 297 Weld₁ 377 359 420 380 390 393 Weld₂ 383 352 429 364 389 393Weld₃ 361 367 433 388 427 398 SS₁ 702 688 666 715 649 639 SS₂ 737 708701 698 701 704 SS₃ 728 692 730 728 713 727

TABLE 1B Region AV1 AV2 AV3 T1 T2 T3 (Average) (HV) (HV) (HV) (HV) (HV)(HV) NiTi 386 380 370 285 294 320 Weld 374 359 427 370 388 391 SS 722696 699 714 688 690

Measurements of the heat affected zone (e.g., weld width) within thestainless steel portion of the multi-segment guide wire were alsoobtained, as presented in Table 1C. The total length of the heataffected zone, including in the nitinol portion, are approximatelydouble the shown values.

TABLE 1C AV2 AV3 T1 T2 T3 AV1 (μm) (μm) (μm) (μm) (μm) Weld — 65-9263-100 235-285 255-308 254-285 Width

FIGS. 9A-9E show images of the multi-segment guide wires AV1-AV3 thatwere measured. FIGS. 10A-10F show images of the Terumo guide wiresT1-T3.

Comparative strength testing was performed on multi-segment guide wiresformed according to methods described above in conjunction with FIGS.4-5. Multi-segment guide wires formed with and without application of afollow up axial force were subjected to destructive rotary bend testing(essentially a low-cycle fatigue test). Tensile testing may not alwayscorrelate to actual performance in bending conditions (which existduring use of the guide wires). For example, while a welding process mayproduce components that exhibit acceptable, even high tensile testvalues, the inventors have found that some such welded componentsperform poorly when subjected to bending.

Rotary bend testing better approximates use conditions, and provides abetter measurement of weld strength during use. In rotary bend testing,the weld of each guide wire was simultaneously bent to a 90° and rotatedone complete revolution (360°) in order to challenge all locationsaround the weld joint perimeter. The test design ensures that the weldinterface will reside near the onset of the 90° bend, and thusparticipate in the curvature. As the applied force incrementallyincreases during testing, the radius of curvature within the turnbecomes tighter, thereby increasing the bend severity and furtherchallenging the weld interface. Each rotary bend test result wasrecorded in psi, representing the actual air pressure being applied, atthe moment of failure, to a piston used to apply the force. Thecross-sectional area of the piston was about 0.1 inch, thus the actualapplied force can be calculated by multiplying any recorded psi value by0.1. The results are shown below in Table 2:

TABLE 2 St. Min Max Range Mean Dev. N (psi) (psi) (psi) (psi) (psi) Cpk(A) Without 405 2.00 4.70 2.70 3.49 0.46 0.94 Follow Up Force (B) With307 2.90 4.80 1.90 3.94 0.33 1.74 Follow Up Force

Each of groups A and B were formed in a manner similar to one another,other than application of the follow up axial force in group B.Manufacturing conditions were as described above in conjunction withFIGS. 4-5. Group A had a significantly lower mean strength value, andthe minimum strength value was only 2.0 psi, which is below a desiredperformance specification of 2.2 psi. Group B included a minimumstrength value of 2.9 psi, well above the desired minimum of 2.2 psi.Cpk is a commonly employed index that quantifies how capable a processis of consistently meeting the desired specification. Higher values ofCpk correspond to better capability in consistently meeting the desiredspecification. Cpk is calculated by dividing the difference between themean value and the specification by 3 standard deviations (i.e.,(mean−2.2)/(3× stdev)). As is readily apparent from Table 2, the Cpkvalue for group B is nearly double the Cpk value for group A.

The comparative testing thus indicates that significantly greaterconsistency with respect to desired strength characteristics is achievedwhen forming the guide wires with application of a follow up axialforce. This is particularly important where the guide wire exhibitingsub specification strength characteristics may not be readilyrecognizable through non-destructive quality control mechanisms. Theinventive method of manufacture thus increases consistency within themanufactured guide wires, while decreasing any incidence of passing subspecification parts.

The embodiments of the present disclosure may be embodied in otherspecific forms without departing from its spirit or essentialcharacteristics. The described embodiments are to be considered in allrespects only as illustrative and not restrictive. Therefore, the scopeof the disclosure is indicated by the appended claims rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

1. A multi-segment guidewire, the guidewire comprising: a first elongateportion of a first material; a second elongate portion of a secondmaterial having a higher modulus of elasticity than a material of thefirst elongate portion; a solid-state deformation region disposed at ajunction of a distal end of the first elongate portion and a proximalend of the second elongate portion, a distal-most end of the firstelongate portion and a proximal-most end of the second elongate portionbeing free of any oxide layers, wherein the distal end and the proximalend are joined without melting of the first material and the secondmaterial.
 2. The multi-segment device of claim 1, further comprising aheat affected zone at the solid-state deformation region, wherein theheat affected zone has an average thickness across the junction of thefirst elongate portion and the second elongate portion of less thanabout 0.20 mm.
 3. The multi-segment device of claim 2, wherein, the heataffected zone has a first thickness, in a direction aligned with alongitudinal axis of the multi-segment device, toward a center of thesolid-state deformation region that is less than a second thickness, inthe direction aligned with the longitudinal axis of the multi-segmentdevice, toward a perimeter of the solid-state deformation region.
 4. Themulti-segment device of claim 1, wherein the distal-most end and theproximal-most end are each flattened and smooth.
 5. The multi-segmentdevice of claim 1, wherein the second elongate portion includes atapered section.
 6. The multi-segment device of claim 1, furthercomprising a coil disposed about at least a portion of the secondelongate portion.
 7. The multi-segment device of claim 1, wherein thesecond elongate portion includes a flattened, shapeable distal tip. 8.The multi-segment device of claim 1, wherein the second elongate portioncomprises a pseudoelastic alloy including about 30 atomic percent toabout 52 atomic percent titanium, up to about 10 atomic percent of oneor more other alloying elements, with a balance of nickel.
 9. Themulti-segment device of claim 8, wherein the one or more other alloyingelements comprises alloying elements selected from iron, cobalt,vanadium, platinum, palladium, copper, and combinations thereof.
 10. Themulti-segment device of claim 1, wherein the heat affected zone has anaverage thickness of less than about 0.18 mm.
 11. The multi-segmentdevice of claim 1, wherein the heat affected zone has an averagethickness from about 0.15 mm to about 0.18 mm.
 12. The multi-segmentdevice of claim 1, wherein second elongate portion comprises anickel-titanium alloy.
 13. The multi-segment device of claim 1 whereinfirst elongate portion comprises stainless steel.
 14. The multi-segmentdevice of claim 1, wherein one of the first elongate portion and thesecond elongate portion comprises a nickel-titanium alloy and the otherof the first elongate portion and the second elongate portion comprisesstainless steel or a cobalt-chromium alloy.
 15. The multi-segment deviceof claim 1, wherein the device exhibits a minimum strength value of atleast 2.9 psi.
 16. The multi-segment device of claim 1, wherein thedevice exhibits a mean strength value of at least 3.94 psi.
 17. Themulti-segment device of claim 1, wherein the device exhibits a Cpk valuewith respect to strength that is greater than 0.94.
 18. Themulti-segment device of claim 11, wherein the device exhibits a Cpkvalue with respect to strength that is at least about 1.74.
 19. Amulti-segment guidewire, the guidewire comprising: a first elongateportion of a first material, the first elongate portion comprising asmooth and flattened distal-most end; a second elongate portion of asecond material having a higher modulus of elasticity than a material ofthe first elongate portion, the second elongate portion comprising asmooth and flattened proximal-most end; a solid-state deformation regionincluding a junction of the distal-most end and the proximal-most end,each being free of any oxide layers, a distal end of the first elongateportion and a proximal end of the second elongate portion are joinedwithout melting of the first material and the second material.
 20. Amulti-segment guidewire, the guidewire comprising: a first elongateportion of a first material, the first elongate portion comprising asmooth and flattened distal-most end; a second elongate portion of asecond material having a higher modulus of elasticity than a material ofthe first elongate portion, the second elongate portion comprising asmooth and flattened proximal-most end; a solid-state deformation regionincluding a junction of the distal-most end and the proximal-most end,each being free of any oxide layers, a distal end of the first elongateportion and a proximal end of the second elongate portion are joinedwithout melting of the first material and the second material, wherein aheat affected zone is formed in the solid-state deformation region, theheat affected zone having an average thickness across the junction ofthe first elongate portion and the second elongate portion of less thanabout 0.20 mm, the heat affected zone having a first thickness toward acenter of the solid-state deformation region, and in a direction alignedwith a longitudinal axis of the multi-segment device, that is less thana second thickness toward a perimeter of the solid-state deformationregion, and in the direction aligned with the longitudinal axis of themulti-segment device.